The Contraception Research Program (CRB) within NICHD supports research to develop compounds that can disrupt normal ovulation, sperm production or sperm function so that safe and effective contraceptives can be developed for men or women. The Biological Testing Facility (BTF) is designed to permit rapid evaluation of new compositions-of-matter, drug formulations, delivery systems, and devices for contraceptive and endocrine activity. The BTF provides overall project management and the capabilities to support all phases of preclinical activities pursuant to development of new contraceptive methods: these include, but are not limited to in vitro and in vivo assays, plasma and microsomal stability studies, absorption, distribution, metabolism, excretion (ADME), toxicity, pharmacokinetic (PK) and pharmacodynamic (PD) profiling, animal activities and studies, manufacture of active pharmaceutical ingredients (APis), process and product development, formulation, clinical lot production, preclinical enabling studies and associated tasks leading to the filing of investigational new drug (IND) applications. The BTF has the capability to prepare compounds under current Good Manufacturing Practices (cGMP) to allow clinical evaluation. The BTF has been working with the CORs for the Chemical Synthesis Facility and the CCTN and with the investigators in the CCTN to develop and test the appropriate formulations for clinical batches of the candidate compounds. The Biological Testing Facility plays a critical role in the drug development mission of the CRB.